Covariate adjustment in randomized controlled trials with dichotomous outcomes increases statistical power and reduces sample size requirements

AV Hernández, EW Steyerberg… - Journal of clinical …, 2004 - Elsevier
OBJECTIVE: Randomized controlled trials (RCTs) with dichotomous outcomes may be
analyzed with or without adjustment for baseline characteristics (covariates). We studied …

A substantial and confusing variation exists in handling of baseline covariates in randomized controlled trials: a review of trials published in leading medical journals

PC Austin, A Manca, M Zwarenstein, DN Juurlink… - Journal of clinical …, 2010 - Elsevier
OBJECTIVE: Statisticians have criticized the use of significance testing to compare the
distribution of baseline covariates between treatment groups in randomized controlled trials …

Randomized controlled trials with time-to-event outcomes: how much does prespecified covariate adjustment increase power?

AV Hernández, MJC Eijkemans, EW Steyerberg - Annals of epidemiology, 2006 - Elsevier
PURPOSE: We evaluated the effects of various strategies of covariate adjustment on type I
error, power, and potential reduction in sample size in randomized controlled trials (RCTs) …

Should we adjust for covariates in nonlinear regression analyses of randomized trials?

WW Hauck, S Anderson, SM Marcus - Controlled clinical trials, 1998 - Elsevier
The analyses of the primary objectives of randomized clinical trials often are not adjusted for
covariates, except possibly for stratification variables. For analyses with linear models …

A tutorial on methods to estimating clinically and policy-meaningful measures of treatment effects in prospective observational studies: a review

PC Austin, A Laupacis - The international journal of biostatistics, 2011 - degruyter.com
In randomized controlled trials (RCTs), treatment assignment is unconfounded with baseline
covariates, allowing outcomes to be directly compared between treatment arms. When …

The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies

BC Kahan, V Jairath, CJ Doré, TP Morris - Trials, 2014 - Springer
Background Adjustment for prognostic covariates can lead to increased power in the
analysis of randomized trials. However, adjusted analyses are not often performed in …

Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials

S Zhang, J Paul, M Nantha-Aree, N Buckley… - Clinical …, 2014 - Taylor & Francis
Background Although seemingly straightforward, the statistical comparison of a continuous
variable in a randomized controlled trial that has both a pre-and posttreatment score …

Ideal vs. real: a systematic review on handling covariates in randomized controlled trials

JD Ciolino, HL Palac, A Yang, M Vaca… - BMC medical research …, 2019 - Springer
Background In theory, efficient design of randomized controlled trials (RCTs) involves
randomization algorithms that control baseline variable imbalance efficiently, and …

Potential misinterpretation of treatment effects due to use of odds ratios and logistic regression in randomized controlled trials

MJ Knol, RG Duijnhoven, DE Grobbee, KGM Moons… - PLoS …, 2011 - journals.plos.org
Background In randomized controlled trials (RCTs), the odds ratio (OR) can substantially
overestimate the risk ratio (RR) if the incidence of the outcome is over 10%. This study …

How to select covariates to include in the analysis of a clinical trial

GM Raab, S Day, J Sales - Controlled clinical trials, 2000 - Elsevier
The comparisons of treatments in randomized clinical trials may use the analysis of
covariance to adjust for patient characteristics. We present theoretical results that describe …